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New Zealand Data Sheet

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New Zealand Data Sheet NEW ZEALAND DATA SHEET 1. PRODUCT NAME Cymevene ® 500 mg powder for intravenous infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 500 mg of ganciclovir (as ganciclovir sodium). After reconstitution with 10 mL of water for injections, each mL provides 50 mg of ganciclovir. Cymevene is available as the sterile lyophilised powder containing ganciclovir sodium 543 mg equivalent to ganciclovir 500 mg and sodium 43 mg (2 mEq). Excipients with known effect: approximately 43 mg (2 mEq) sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion (powder for infusion) White to off-white solid cake. Ganciclovir, when formulated as monosodium salt in the intravenous (IV) dosage form, is a white to off-white lyophilised powder. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Cymevene (ganciclovir) administered as the IV infusion is indicated for the palliative treatment of confirmed sight-threatening cytomegalovirus (CMV) disease in AIDS and other severely immunocompromised individuals. It is indicated for the treatment of confirmed CMV pneumonitis in bone marrow transplant patients. It is also indicated for the prophylaxis of CMV infection and disease following bone marrow and solid organ transplantation in patients at risk of CMV disease. NOTE: Cymevene (ganciclovir) is not indicated for congenital or neonatal CMV disease; nor for the treatment of CMV infection in non-immunocompromised individuals. 4.2 Dose and method of administration General Cymevene must be reconstituted and diluted under the supervision of a healthcare professional and administered as an intravenous infusion (see section 4.2). Caution: Cymevene must only be administered by IV infusion over 1 hour, preferably via a plastic cannula, into a vein with adequate blood flow (intramuscular or subcutaneous injection may result in severe tissue irritation due to the high pH (~11) of ganciclovir Cymevene® DS 181120 1 NEW ZEALAND DATA SHEET solutions). Do not administer by rapid or bolus IV injection because the resulting excessive plasma levels may increase the toxicity of Cymevene. (see section 4.2). The recommended dosage, frequency or infusion rates should not be exceeded. Because of individual patient variations in the clinical response of CMV disease and the sensitivity to the myelosuppressive effects of Cymevene, the treatment of each patient with Cymevene should be individualised on a case-by-case basis. Changes in dose should be based on regular clinical evaluations as well as by regular haematologic monitoring. Standard dosage for Treatment of CMV Disease Dosage for patients with normal renal function Induction Treatment Cymevene 5 mg/kg given as an IV infusion over 1 hour every 12 hours (10 mg/kg/day) for 14 to 21 days Maintenance Treatment For immunocompromised patients at risk of relapse maintenance therapy may be given. The recommended dose is Cymevene 6 mg/kg given over 1 hour, once daily, 5 days per week, or 5 mg/kg once daily 7 days per week. The duration of maintenance treatment should be determined on an individual basis. Treatment of Disease Progression Any patient in whom the disease progresses, either while on maintenance treatment or because treatment with Cymevene was withdrawn, may be re-treated using the IV induction treatment regimen. The frequency and duration of response in such patients has not been adequately established. Indefinite treatment may be required in patients with AIDS, but even with continued maintenance treatment, patients may have progression of CMV disease. Standard dosage for the Prevention of CMV Disease in Transplant Recipients for Patients with Normal Renal Function The duration of treatment with Cymevene solution in transplant recipients is based on the risk of CMV disease and should be determined on an individual basis. Liver Transplantation The recommended initial dosage of Cymevene solution is 5 mg/kg infused at a constant rate over 1 hour every 12 hours (10 mg/kg/day) for 7 to 14 days, followed by 5 mg/kg once daily 7 days a week or 6 mg/kg once daily 5 days a week for up to 100 days post-transplant. Heart Transplantation The recommended initial dosage of Cymevene solution is 5 mg/kg infused at a constant rate over 1 hour every 12 hours (10 mg/kg/day) for 14 days, followed by 6 mg/kg once daily 5 days a week for up to 100 days post-transplant. In a controlled clinical trial in heart allograft recipients, the onset of newly diagnosed CMV disease occurred after treatment with IV Cymevene was stopped at day 28 post-transplant, Cymevene® DS 181120 2 NEW ZEALAND DATA SHEET suggesting that continued dosing may be necessary to prevent late occurrence of CMV disease in this patient population. Bone Marrow Transplantation The recommended initial dosage of Cymevene solution is 5 mg/kg infused at a constant rate over 1 hour every 12 hours (10 mg/kg/day) for 7 days, followed by 5 mg/kg once daily 7 days a week for up to 100 to 120 days post-transplant. In controlled clinical trials in bone marrow allograft recipients, CMV disease occurred in several patients who discontinued treatment with Cymevene solution prematurely. Other Transplantations The recommended initial dosage of Cymevene solution is 5 mg/kg infused at a constant rate over 1 hour every 12 hours (10 mg/kg/day) for 7 to 14 days, followed by 5 mg/kg once daily 7 days a week or 6 mg/kg once daily on 5 days a week. Special Dosage Instructions Renal Impairment For patients with impaired renal function, the IV dose of Cymevene should be modified as shown in the table below. The following recommended dosages in renal impairment are not based on experience in patients with AIDS. Table 1: Cymevene dosing for renally impaired patients Creatinine Serum Cymevene Dosing Cymevene Dosing Clearance Creatinine Induction Interval Maintenance Interval Dose Dose (mL/min) (micromol/L) (mg/kg) (hours) (mg/kg) (hours) ≥ 70 < 125 5.0 12 5.0 24 50 - 69 125 - 175 2.5 12 2.5 24 25 - 49 176 - 350 2.5 24 1.25 24 Cymevene® DS 181120 3 NEW ZEALAND DATA SHEET Creatinine Serum Cymevene Dosing Cymevene Dosing Clearance Creatinine Induction Interval Maintenance Interval Dose Dose 10 - 24 > 350 1.25 24 0.625 24 < 10 > 350 (and on 1.25 3 times per 0.625 3 times per haemodialysis) week, week following following haemodialysis haemodialysis To calculate an estimated creatinine clearance: For males = (140 - age [years]) x (body weight [kg]) (72) x (0.011 x Serum Creatinine [micromol/L]) For females = 0.85 x male value Hepatic impairment The safety and efficacy of Cymevene have not been studied in patients with hepatic impairment (see section 5.2). Elderly No studies on the efficacy or safety of Cymevene have been conducted specifically in elderly patients. Since elderly individuals may have reduced renal function, Cymevene should be administered to the elderly patients with care and with special consideration of their renal status (see section 4.2). Paediatric population Safety and efficacy of ganciclovir in paediatrics have not been established, including use for the treatment of congenital or neonatal CMV infections. The use of Cymevene in children warrants extreme caution due to the potential for long-term carcinogenicity and reproductive toxicity. The benefits of treatment should outweigh the risks. Method of Administration Based on patient weight the appropriate calculated dose volume should be removed from the vial (Cymevene concentration 50 mg/mL) and added to an acceptable infusion fluid (typically 100 mL) for delivery over the course of one hour. Infusion concentrations greater than 10 mg/mL are not recommended. The following infusion fluids are compatible with Cymevene: normal saline, glucose 5% in water, Ringer's Injection, Ringer-Lactate Solution for Injection. For instructions on reconstitution and dilution of the medicine before administration, see section 6.6. 4.3 Contraindications Cymevene® DS 181120 4 NEW ZEALAND DATA SHEET Cymevene is contraindicated in pregnant women, nursing mothers, and in patients who are hypersensitive to ganciclovir, valganciclovir or to any of the excipients. Cymevene should not be administered to patients if the absolute neutrophil count falls below 0.5 x 109/L (500 cells/µL) or platelet count below 2.5 x 1010/L (25,000/µL) or the haemoglobin is less than 80 g/L (8 g/dL). The safety and efficacy of Cymevene have not been evaluated for prophylaxis of CMV disease in donor negative/receptor negative (D-/R-) transplant patients, or in populations other than those stated under Therapeutic Indications, section 4.1. 4.4 Special warnings and precautions for use General The main clinical toxicities of ganciclovir include leucopenia, anaemia and thrombocytopenia. Cymevene is only indicated in those patients as outlined under Therapeutic Indications in section 4.1 where the potential benefits to the patient outweigh the risks stated herein. It is recommended that complete blood counts and platelet counts be monitored during therapy. The diagnosis of CMV retinitis should be made by indirect ophthalmoscopy. Other conditions in the differential diagnosis of CMV retinitis included candidiasis, toxoplasmosis, histoplasmosis, retinal scars, cotton wool spots, any of which may produce a retinal appearance similar to CMV. For this reason it is essential that the diagnosis of CMV be established by an ophthalmologist familiar with the presentation of these conditions. The diagnosis of CMV retinitis may be supported by culture of CMV in the urine, blood, throat, or other sites, but a negative culture does not rule out CMV retinitis. HIV+ Patients with CMV Retinitis: Ganciclovir is not a cure for CMV retinitis, and immunocompromised patients may continue to experience progression of retinitis during or following treatment. Patients should be advised to have ophthalmologic follow-up examinations at a minimum of every 4 to 6 weeks while being treated with Cymevene.
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